NEWS FROM USA
505(b)(2) APPROVAL
|
Approval Date |
Product Name |
NDA Sponsor |
Comment |
|
10 Sep 2019 |
Glucagon Injectable – Prefilled syringes and autoinjector (Gvoke) |
Xeris Pharma |
Gvoke is the first ready-to-use Glucacgon injectable formulation approved in the US. Currently available two other emergency Glucagon products (From Lilly and Novo Nordisk) are lyophilized formulations that require reconstitution with diluent. Another Glucagon product from Fresenius is also lyophilized powder. Fresenius’ Glucagon was marketed only as diagnostic aid. Recently on 9th September, Fresenius received approval to market its Glucagon product for the treatment of hypoglycaemia. Comparison between Glucagon by Lilly, Novo Nordisk and Xeris is available here. |
NEW GENERICS LAUNCHES IN US
|
LAUNCH DATE |
DRUG |
Marketer |
Corresponding RLD |
Annual sales quoted in press release as per IQVIA |
Press Release |
|
11 Sep 2019 |
Fosaprepitant injection |
Dr Reddy |
Emend (Merck) |
$279 Million |
|
|
09 Sep 2019 |
Phenylephrine Injections (5 ml and 10 ml) |
Hikma Pharma |
N/A |
$28 Million |
|
|
05 Sep 2019 |
Fosaprepitant injection |
Apotex |
Emend (Merck) |
$279 Million |
|
|
05 Sep 2019 |
Bupropion Hydrochloride ER Tablets |
Dr Reddy |
Zyban (GSK) |
$5.4 Million |
NEW EXCLUSIVITY LISTINGS IN THE ORANGE BOOK
New PC (Patent Challenge) exclusivity listing in the orange book
|
Drug |
Applicant |
Corresponding RLD |
PC exclusivity expiration date |
|
Nicotine Polacrilex oral lozenges |
PLD acquisitions |
Nicorette (Glaxo) |
New CGT (competitive generic therapy) exclusivity listing in the orange book
|
Drug |
Applicant |
Corresponding RLD |
CGT exclusivity expiration date |
|
Aminocaproic acid oral syrup |
Amneal |
Amicar (Clover) |
Complete List of products with granted CGT exclusivity till date is available here.
NEW STRENGTH APPROVALS
Write us on pharmacaption@gmail.com, if you want to know new strengths approved in existing NDAs during August 2019.
OTHER NEWS FROM US
FDA issued alert statement on NDMA (probable carcinogen) found in the samples of Ranitidine - Link
If you have any query/suggestion then please write us at pharmacaption@gmail.com
No comments:
Post a Comment